Personal Genome Diagnostics Inc, Baltimore, a leading cancer genomics company and pioneer in liquid biopsy, has announced that the company’s Elio Plasma Resolve has received a breakthrough device designation from FDA’s Center for Devices and Radiological Health (CDRH).
Elio Plasma Resolve is a qualitative in vitro diagnostic that uses targeted high-throughput, parallel-sequencing technology to detect single nucleotide variants, small insertion/deletions, amplifications, rearrangements, and microsatellite instability (MSI) in a broad multigene panel, using circulating cell-free DNA isolated from plasma samples.
FDA granted the breakthrough designation based on the assay’s ability to detect MSI status in plasma as an aid in selecting cancer patients for certain immunotherapies.
Breakthrough device designation helps give patients timely access to medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions, by expediting their development, assessment, and review. The designation was granted to Elio Plasma Resolve based on response rate, progression free survival, and overall survival data, which showed that the test may help patients who are unable to provide tissue samples but could benefit from genomic testing.
“We are excited about what breakthrough device designation for Elio Plasma Resolve will mean for people with cancer,” says Doug Ward, CEO of Personal Genome Diagnostics. “If approved, this test could be the first liquid biopsy test that can be kitted and run in laboratories worldwide, and is an important advancement for patients who cannot give tissue samples. As a leader in liquid biopsy innovation, our goal is to deliver these tests to clinicians locally and expand patient access to leading scientific advances in medicine.”
“This breakthrough designation is a continuation of our leadership with MSI,” says John Simmons, PhD, director of translational science and diagnostics at Personal Genome Diagnostics. “PGDx was the first CAP/CLIA lab to offer MSI testing with next-generation sequencing, and the first to offer MSI testing in plasma. We’re now focused on bringing these innovative technologies to patients globally by empowering clinicians with actionable information about a patient’s cancer that can change the course of clinical therapy and, ultimately, improve outcomes.”
To learn more, visit Personal Genome Diagnostics.